BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFESHEATH® II INTRODUCER SET

    MDR report key: 23881208 · Received December 23, 2025

    Report

    Report Number
    1035166-2025-00068
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    October 15, 2025
    Report Date
    December 23, 2025
    Manufacturer
    OSCOR INC.
    Product Code
    DYB
    UDI-DI
    30891492002259
    PMA / PMN Number
    K122084
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    DIAPHRAGM DOES NOT PEEL STAYS INTACT AROUND CATHETER. PATIENT EXPERIENCED SERIOUS OR IMPORTANT MEDICAL EVENTS. THE EVENT DATE WAS (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507651 SAFESHEATH® II INTRODUCER SET INTRODUCER, CATHETER DYB OSCOR INC. SS9 DP20061 30891492002259

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other